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DUROGESIC DTRANS 100MCG /HR TRANSDERMAL PATCH

Active substance(s): FENTANYL / FENTANYL / FENTANYL

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Package leaflet: Information for the user

Durogesic® DTrans® 100mcg/hr Transdermal Patch
(fentanyl)
The name of your medicine is Durogesic DTrans 100mcg/hr Transdermal
Patch but will be referred to as Durogesic DTrans throughout this leaflet.
Please note that the leaflet also contains information about other strengths
Durogesic DTrans 12, 25, 50, 75mcg/hr Transdermal Patch.

Important things you need to know about Durogesic DTrans








These patches contain a strong pain killer
Ensure that old patches are removed before applying a new one
Patches must not be cut
Do not expose the patches to a heat source (such as a hot water
bottle)
If you develop a fever tell your doctor immediately
Follow the dosage instructions carefully and only change your patch
every 3 days (72 hours)
If your breathing becomes shallow and weak take the patch off and
seek medical help

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.





Keep this leaflet. You may need to read it again
If you have any further questions, ask your doctor, pharmacist or nurse
This medicine has been prescribed for you (or your child) only. Do not
pass it on to others. It may harm them, even if their signs of illness are
the same as yours
If you get side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1

What Durogesic DTrans is and what it is used for

2

What you need to know before you use Durogesic DTrans

3

How to use Durogesic DTrans

4

Possible side effects

5

How to store Durogesic DTrans

6

Contents of the pack and other information

1. What Durogesic DTrans is and what it is used for
The patches help relieve pain that is very bad and long-lasting:
 in adults who need continuous pain treatment
 in children above 2 years of age who are already using opioid
medication and who need continuous pain treatment.
Durogesic DTrans contains a medicine called fentanyl. It belongs to a group
of strong painkillers called opioids.

2. What you need to know before you use Durogesic
DTrans
Do not use Durogesic DTrans if:


You are allergic to fentanyl or any of the other ingredients of this
medicine (listed in section 6)
 You have pain which lasts only for a short period, such as sudden pain
or pain after having an operation
 You have breathing difficulties, with slow or shallow breathing.
Do not use this medicine if any of the above apply to you or your child. If you
are not sure, talk to your doctor or pharmacist before using
Durogesic DTrans.

Warnings and precautions



Durogesic DTrans can have life-threatening side effects in people
who are not already regularly using prescribed opioid medicines.
Durogesic DTrans is a medicine that could be life-threatening to
children, even if the patches have been used. Bear in mind that a
sticky patch (unused or used) could be tempting to a child and if it
sticks to a child’s skin or they put it in their mouth, the result may be
fatal.

Patch sticking to another person
The patch should be used only on the skin of the person for whom it has
been prescribed. There have been reports of patches accidentally sticking to
a family member while in close physical contact or sharing the same bed as
the person wearing the patch. A patch accidently sticking to another person
(particularly a child) can cause the medicine in the patch to go through the
skin of the other person and cause serious side effects such as breathing
difficulties, with slow or shallow breathing which may be fatal. In case the
patch sticks to the skin of another person, take the patch off right away and
get medical attention.

Take special care with Durogesic DTrans
Talk to your doctor or pharmacist before using this medicine if any of the
following apply to you - your doctor may need to check you more closely if:
 You have ever had problems with your lungs or breathing
 You have ever had problems with your heart, liver, kidneys, or low blood
pressure
 You have ever had a brain tumour
 You have ever had persistent headaches or a head injury
 You are elderly - you may be more sensitive to the effects of this
medicine
 You have a condition called ‘myasthenia gravis’ in which muscles
become weak and tire easily
 You have ever abused or been dependent on alcohol, prescription
medicines or illegal drugs
If any of the above apply to you (or you are not sure), talk to your doctor or
pharmacist before using Durogesic DTrans.












Durogesic DTrans with antidepressants
The risk of side effects increases if you are taking medicines such as certain
antidepressants. Durogesic DTrans may interact with these medicines and
you may experience changes to mental status such as feeling agitated,
seeing, feeling, hearing, or smelling things that are not there (hallucinations)
and other effects such as changing blood pressure, fast heart beat, high
body temperature, overactive reflexes, lack of coordination, muscle
stiffness, nausea, vomitting and diarrhoea.

Operations

Side effects and Durogesic DTrans

If you think that you are going to receive anaesthesia tell your doctor or
dentist that you are using Durogesic DTrans.



Durogesic DTrans and alcohol

Durogesic DTrans may make you unusually drowsy, and make your
breathing more slow or shallow. Very rarely these breathing problems
can be life-threatening or even fatal, especially in people who have not
used strong opioid painkillers (like Durogesic DTrans or morphine)
before. If you, or your partner or carer, notice that the person wearing
the patch is unusually drowsy, with slow or shallow breathing:
- Take the patch off
- Call a doctor, or go to your nearest hospital straight away
- Keep the person moving and talking as much as possible
 If you get a fever while using Durogesic DTrans, tell your doctor - this
may increase the amount of medicine that passes through your skin
 Durogesic DTrans may cause constipation, talk to your doctor or
pharmacist for advice on how to prevent or relieve constipation.
 Repeated, long term use of the patches may make the medicine less
effective (you become ‘tolerant’ to it) or you may become dependent on
it.
See section 4 for a full list of possible side effects.
When you are wearing the patch do not expose it to direct heat such as
heating pads, electric blankets, hot-water bottles, heated water beds or
heat or tanning lamps. Do not sunbathe, have long hot baths or saunas or
use hot whirlpool spa baths. If you do, you may increase the amount of
medicine you get from the patch.

Other medicines and Durogesic DTrans
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This includes medicines that you buy without a
prescription or herbal medicines. You should also tell your pharmacist that
you are using Durogesic DTrans if you buy any medicines from your
pharmacy.
Your doctor will know which medicines are safe to take with Durogesic
DTrans. You may need to be closely monitored if you are taking some of the
types of medicines listed below or if you stop taking some of the types of
medicines listed below, as this may affect the strength of Durogesic DTrans
you need.
In particular, tell your doctor or pharmacist if you are taking:
 Other medicines for pain, such as other opioid painkillers (such as
buprenorphine, nalbuphine, or pentazocine).
 Medicines for helping you sleep (such as temazepam, zaleplon, or
zolpidem).
 Medicines to help you calm down (tranquillisers, such as alprazolam,
clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for
mental conditions (antipsychotics, such as aripiprazole, haloperidol,
olanzapine, risperidone, or phenothiazines).
 Medicines for relaxing your muscles (such as cyclobenzaprine or
diazepam).
 Some medicines used to treat depression called SSRIs or SNRIs (such
as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine,
paroxetine, sertraline, or venlafaxine). – see below for more information.
 Some medicines used to treat depression or Parkinson’s disease called
MAOIs (such as isocarboxazid, phenelzine, selegiline, or
tranylcypromine). You should not take Durogesic DTrans within 14 days
of stopping these medicines. – see below for more information.
 Some antihistamines, especially ones that make you sleepy (such as
chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or
hydroxyzine).

Apply your patch
on

Some antibiotics used to treat infection (such as erythromycin or
clarithromycin.
Medicines used to treat fungal infection (such as itraconazole,
ketoconazole, fluconazole, or voriconazole).
Medicines used to treat HIV infection (such as ritonavir).
Medicines used to treat an irregular heart beat (such as amiodarone,
diltiazem, or verapamil).
Medicines to treat tuberculosis (such as rifampicin).
Some medicines used to treat epilepsy (such as carbamazepine,
phenobarbital, or phenytoin).
Some medicines used to treat nausea or motion sickness (such as
phenothiazines).
Some medicines used to treat heartburn or ulcers (such as cimetidine).
Some medicines used to treat angina (chest pain) or high blood
pressure (such as nicardipine).
Some medicines used to treat cancer of the blood (such as idelalisib).

Do not drink alcohol while using Durogesic DTrans unless you have talked
to your doctor first.
Durogesic DTrans can make you drowsy or breathe more slowly. Drinking
alcohol may make these effects worse.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Durogesic DTrans should not be used during pregnancy unless you have
discussed this with your doctor.
Durogesic DTrans should not be used during childbirth as the medication
can affect the breathing of the newborn child.
Do not use Durogesic DTrans if you are breastfeeding. You should not
breastfeed for 3 days after removing your Durogesic DTrans patch. This is
because the medicine may pass into breast milk.

Driving and using machines
Durogesic DTrans can affect your ability to drive and use machines or tools
as it may make you sleepy or dizzy. If this happens, do not drive or use any
tools or machines.
 Do not drive while taking this medicine until you know how it affects you.
 It is an offence to drive if this medicine affects your ability to drive.
 However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental
problem and
- You have taken it according to the instructions given by the prescriber
or in the information provided with the medicine and
- It was not affecting your ability to drive safely

Change
your patch on

Monday

Thursday

Tuesday

Friday

Wednesday

Saturday

Thursday

Sunday

Friday

Monday

Saturday

Tuesday

Sunday

Wednesday

Where to apply the patch
Adults
 Apply the patch on a flat part of your upper body or arm (not over a
joint).
Children
 Always apply the patch to the upper back to make it difficult for your
child to reach it or take it off .
 Every so often check that the patch remains stuck to the skin.
 It is important that your child does not remove the patch and put it in
their mouth as this could be life threatening or even fatal.
 Watch your child very closely for 48 hours after:
- The first patch has been put on
- A higher dose patch has been put on
 It may take some time for the patch to have its maximum effect.
Therefore, your child might need to use other painkillers as well until the
patches become effective. Your doctor will talk to you about this.
Adults and Children:
Do not apply the patch on
 The same place twice in a row.
 Areas that you move a lot (joints), skin that is irritated or with cuts.
 Skin that is very hairy. If there is hair, do not shave it (shaving irritates
the skin). Instead, clip the hair as close to the skin as possible.

Putting a patch on
Step 1: Preparing the skin
 Make sure your skin is completely dry, clean and cool before you put the
patch on
 If you need to clean the skin, just use cold water
 Do not use soap or any other cleansers, creams, moisturisers, oils or
talc before applying the patch
 Do not stick a patch on straight after a hot bath or shower
Step 2: Open the sachet
 Each patch is sealed in its own sachet
 Tear or cut open the sachet at the notch, shown by the arrow
 Gently tear or cut off the edge of the sachet completely (if you use
scissors, cut close to the sealed edge of the sachet to avoid damaging
the patch)

Talk to your doctor or pharmacist if you are not sure whether it is safe for
you to drive while taking this medicine.

3. How to use Durogesic DTrans
Always use this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Your doctor will decide which strength of Durogesic DTrans is most suitable
for you, taking into account the severity of your pain, your general condition
and type of pain treatment that you have received so far.
Using and changing the patches
 There is enough medicine in each patch to last 3 days (72 hours).
 You should change your patch every third day, unless your doctor has
told you differently.
 Always remove the old patch before applying a new one.
 Always change your patch at the same time of day every 3 days
(72 hours).
 If you are using more than one patch, change all your patches at the
same time.
 Make a note of the day, date and time you apply a patch, to remind you
when you need to change your patch.
 The following table shows you when to change your patch:










Grasp both sides of the opened sachet and pull apart
Take the patch out and use straight away
Keep the empty sachet to dispose of the used patch later
Use each patch once only
Do not take the patch out of its sachet until you are ready to use it
Inspect the patch for any damage
Do not use the patch if it has been divided, cut or looks damaged
Never divide or cut the patch

Step 3: Peel and press
 Make sure that the patch will be covered by loose clothing and not stuck
under a tight or elasticated band
 Carefully peel one half of the shiny plastic backing away from the centre
of the patch. Try not to touch the sticky side of the patch
 Press this sticky part of the patch onto the skin
 Remove the other part of the backing and press the whole patch onto
the skin with the palm of your hand
 Hold for at least 30 seconds. Make sure it sticks well, especially the
edges

Step 4: Disposing of the patch
 As soon as you take a patch off, fold it firmly in half so that the sticky
side sticks to itself
 Put it back in its original sachet and dispose of the sachet as instructed
by your pharmacist
 Keep used patches out of sight and reach of children – even used
patches contain some medicine which
may harm children and may even be fatal
Step 5: Wash
 Always wash your hands after you have handled the patch using clean
water only

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

If you or your partner, or carer, notice any of the following
about the person wearing the patch, take the patch off and call
a doctor, or go to your nearest hospital, straight away. You
may need urgent medical treatment.


More about using Durogesic DTrans
Everyday activities while using the patches
 The patches are waterproof
 You can shower or bathe while wearing a patch, but do not scrub the
patch itself
 If your doctor agrees, you can exercise or play sport while wearing the
patch
 You can also swim while wearing the patch, but:
- Don’t use hot whirlpool spa baths
- Don’t put a tight or elasticated band over the patch
 While you are wearing the patch do not expose it to direct heat such as
heating pads, electric blankets, hot-water bottles, heated water beds,
heat or tanning lamps. Do no sunbathe, have long hot baths or saunas.
If you do, you may increase the amount of medicine you get from the
patch.

How quickly will the patches work?




It may take some time for your first patch to have its maximum effect.
Your doctor may give you other painkillers as well for the first day or so
After this, the patch should help to relieve pain continuously so that you
can stop taking other painkillers. However, your doctor may still
prescribe extra painkillers from time to time

How long will you use the patches for?


Durogesic DTrans are for long-term pain. Your doctor will be able to tell
you how long you can expect to use the patches

If your pain gets worse



If your pain gets worse while you are using these patches, your doctor
may try a higher strength patch, or give you additional painkillers (or
both)
If increasing the strength of the patch does not help, your doctor may
decide to stop the use of the patches

If you use too many patches or the wrong strength patch
If you have stuck on too many patches or the wrong strength patch, take the
patches off and contact a doctor straight away.
Signs of overdose include trouble breathing or shallow breathing, tiredness,
extreme sleepiness, being unable to think clearly, walk or talk normally and
feeling faint, dizzy or confused.

If you forget to change your patch



If you forget, change your patch as soon as you remember and make
note of the day and time. Change the patch again after 3 days
(72 hours) as usual.
If you are very late changing your patch, you should talk to your doctor
because you might need some extra painkillers, but do not apply an
extra patch.

If a patch falls off





If a patch falls off before it needs changing, stick a new one on straight
away and make note of the day and time. Use a new area of skin on:
- Your upper body or arm
- Your child’s upper back
Let your doctor know this has happened and leave the patch on for
another 3 days (72 hours) or as directed by your doctor, before
changing the new patch as usual
If your patches keep falling off, talk to your doctor, pharmacist or nurse

If you want to stop using the patches



Talk to your doctor before you stop using these patches
If you have been using them for some time your body may have got
used to them. Stopping suddenly may make you feel unwell
 If you stop using the patches, don’t start again without asking your
doctor first. You might need a different patch strength when you restart
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.





Feeling unusually drowsy, breathing that is more slow or shallow than
expected. Follow the advice above and keep the person who was
wearing the patch moving and talking as much as possible. Very rarely
these breathing difficulties can be life-threatening or even fatal,
especially in people who have not used strong opioid painkillers (like
Durogesic DTrans or morphine) before. (Uncommon, this may affect up
to 1 in 100 people)
Sudden swelling of the face or throat, severe irritation, reddening or
blistering of your skin. These may be signs of a severe allergic reaction.
(frequency cannot be estimated from the available data.)
Fits (seizures). (Uncommon, this may affect up to 1 in 100 people.)
Reduced consciousness or loss of consciousness. (Uncommon, these
may affect up to 1 in 100 people.)

The following side effects have also been reported
Very common (may affect more than 1 in 10 people)





Nausea, vomiting, constipation
Feeling sleepy (somnolence)
Feeling dizzy
Headache

Common (may affect up to 1 in 10 people)






















Allergic reaction
Loss of appetite
Difficulty sleeping
Depression
Feeling anxious or confused
Seeing, feeling, hearing, or smelling things that are not there
(hallucinations)
Muscle tremors or spasms
Unusual feeling in the skin, such as tingling or crawling feelings
(paraesthesia)
Spinning sensation (vertigo)
Heart beat feels fast or uneven (palpitations, tachycardia)
High blood pressure
Being short of breath (dyspnoea)
Diarrhoea
Dry mouth
Stomach pain or indigestion
Excessive sweating
Itching, skin rash or redness of the skin
Being unable to pass urine or empty bladder completely
Feeling very tired, weak or generally unwell
Feeling cold
Swollen hands, ankles or feet (peripheral oedema)

Uncommon (may affect up to 1 in 100 people)















Feeling agitated or disoriented
Feeling extremely happy (euphoria)
Decreased feeling or sensitivity, especially in the skin
(hypoaesthesia)
Loss of memory
Blurred vision
Slow heart beat (bradycardia) or low blood pressure
Blue colour to the skin caused by low oxygen in the
blood (cyanosis)
Loss of contractions of the gut (ileus)
Itchy skin rash (eczema), allergic reaction or other skin
disorders where the patch is placed
Flu-like illness
Feeling of body temperature change
Fever
Muscle twitching
Difficulty getting and keeping an erection (impotence)
or problems having sex

Rare side effects (may affect up to 1 in 1000 people)



Constricted pupils (miosis)
Stopping breathing from time to time (apnoea)

You may notice rashes, redness or slight itching of the skin at the site of the
patch. This is usually mild and disappears after you have removed the
patch. If it does not, or if the patch irritates your skin badly, tell your doctor.
Repeated use of the patches may make the medicine become less effective
(you become ‘tolerant’ to it) or become dependent on it.

If you switch from a different painkiller to Durogesic DTrans or if you
suddenly stop using Durogesic DTrans, you may notice withdrawal effects
such as sickness, feeling sick, diarrhoea, anxiety or shivering. Tell your
doctor if you notice any of these effects.
There have been reports also of newborn infants experiencing withdrawal
effects after their mothers have used Durogesic DTrans for a long time
during pregnancy.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store Durogesic DTrans
Where you should keep the Durogesic DTrans
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package.
Ensure that the sachets with transdermal systems are kept together and
intact.

How long to keep Durogesic DTrans for
Do not use the patch after the expiry date which is stated on the carton and
sachet label after ‘Exp’. The expiry date refers to the last day of that month.
If the patches are out of date, take them to your pharmacy.
If the patch becomes discoloured or show any sign of deterioration, seek the
advice of your pharmacist.
Remember if your doctor tells you to stop using these patches, return any
unused patch to your pharmacist for safe disposal. Only keep this patch if
your doctor tells you to.

How to dispose of Durogesic DTrans
A used or unused patch accidentally sticking to another person, especially a
child, may be fatal.
Used patches, should be folded firmly in half so that the sticky side of the
patch sticks to itself. Then they should be safely discarded by putting them
back into the original sachet and stored out of sight and reach of other
people, especially children, until safely disposed. Ask your pharmacist how
to throw away medicines you no longer use.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. Contents of the pack and other information
What Durogesic DTrans contains
The active substance is fentanyl.
Each transdermal patch contains 16.8mg fentanyl (absorption rate approx
100 micrograms/hour; active surface area 42cm 2).
The other ingredients are polyethylene terephthalate / ethylene vinyl acetate
(backsheet), duro-Tak 87-4287 (layer of active substance), siliconised
polyethylene terephthalate (protective film), printing ink grey.

What Durogesic DTrans looks like and contents of the pack
Each patch is a rectangular shaped, clear patch with a sticky back and
marked with ‘Durogesic® 100 µg fentanyl/h’ in grey printing ink.
It comes in packs containing 5 patches.

Manufactured by: Janssen Pharmaceutica N.V., Turnhoutseweg 30,
2340 Beerse, Belgium.

Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
®

®

Durogesic DTrans 100mcg/hr Transdermal Patch;
PL 18799/2306
Leaflet date: 16.05.2017

POM

CD

Durogesic and DTrans are registered trademarks of Janssen Cilag.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for you.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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